04/01/2014

Tomorrow, April 3rd, is a full day Quality Risk Management Seminar at the 5th Proactive GCP Compliance Conference in DC.

In the seminar we look at how compliance activities related to the Predicate Rules are changing and discuss how this may change inspection citation evidence for findings such as INADEQUATE MONITORING . . . [instead of THE MONITOR failed to . . . Will it change to You FAILED to RECOGNIZE the RISK LEVEL and implement adequate monitoring activities to MITIGATE the RISK . . . .] Thoughts?

In the Panel discussion on APRIL 3rd we poll the audience and also discuss the following:

Specific risk indicators being used to uncover current and potential problem areas

Strategies for establishing appropriate tolerance levels for these indicators

Best practices for conducting risk assessment to determine gaps and high risk areas AND When to do a reassessment and what risk indicators to use